CARBAMAZEPINE (CARBAMAZEPINE)

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Trade Name: CARBAMAZEPINE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 200 mg/1

Storage and handling

CARBAMAZEPINE Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

Rx Only

WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND HLA-Bn n n 1502 ALLELEn nn
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH CARBAMAZEPINE UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE n n n AND PRECAUTIONS, n n n ).n nn
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

Before prescribing carbamazepine, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.

Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 100 mg, 200 mg, 300 mg, 400 mg. Its chemical name is n n n -dibenz[n n n ]azepine-5-carboxamide, and its structural formula is: n nn
Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27.
Carbamazepine tablets, USP, 100 mg, 200 mg, 300 mg and 400 mg contain the inactive ingredients: colloidal silicon dioxide, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, pregelatinized maize starch, corn starch, and sodium starch glycolate.
Carbamazepine tablets, USP, (chewable) contain the inactive ingredients: artificial flavors, colloidal silicon dioxide, compressible sugar, corn starch, FD&C Red #40 aluminum lake, hydroxypropyl methyl cellulose, magnesium stearate, and sodium starch glycolate.
Carbamazepine tablets, USP, 100 mg, 200 mg, 300 mg, and 400 mg meet USP Dissolution Test 2 and Carbamazepine Tablets USP (Chewable), 100 mg meet USP Dissolution Test 1.

In controlled clinical trials, carbamazepine has been shown to be effective in the treatment of psychomotor and grand mal seizures, as well as trigeminal neuralgia.

No data

Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be disu00a0continued for a minimum of 14 days, or longer if the clinical situation permits.
Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Coadministration of carbamazepine with nefazodone is contraindicated.

No data

No data

If adverse reactions are of such severity that the drug must be discontinued, the physiu00a0cian must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.
The most severe adverse reactions have been observed in the hemopoietic system and skin (see boxed WARNING), the liver, and the cardiovascular system.
The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.
The following additional adverse reactions have been reported:
Arrayn- Hemopoietic System:
Arrayn- Skin:
Arrayn- Cardiovascular System:
Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.
Arrayn- Liver:
Arrayn- Pancreatic:
Arrayn- Respiratory System:
Arrayn- Genitourinary System:
Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related inciu00a0dence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.
Arrayn- Nervous System:
There have been reports of associated paralysis and other symptoms of cerebral arteu00a0rial insufficiency, but the exact relationship of these reactions to the drug has not been established.
Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomiu00a0tant use of psychotropic drugs.
Arrayn- Digestive System:
Arrayn- Eyes:
Arrayn- Musculoskeletal System:
Arrayn- Metabolism:
Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycu00a0erides in patients taking anticonvulsants.
A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medu00a0ications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

No data

DOSAGE AND ADMINISTRATION n- (see table below)
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the indiu00a0vidual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the miniu00a0mum effective level. Medication should be taken with meals.
u00a0
Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).
u00a0
Epilepsy
Arrayn- Array
Arrayn- Array
Arrayn- Array
Arrayn- Combination Therapy:
Trigeminal Neuralgia
Arrayn- Array

Carbamazepine Tablets, USP, 200 mg are available in the following form: pink colored, capsule shaped, biconvex tablets with '268' debossed on one side and scored on the other side.
Bottle of 30 NDC 66267-268-30
Bottle of 90 NDC 66267-268-90
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. n n n
Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.
8057712 Revised November 2015

MEDICATION GUIDE
Carbamazepine n- (kar ba MAZ e peen) n- Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine n- (kar ba MAZ e peen)n- Tablets, USP (Chewable), 100 mg
Rx Only
Read this Medication Guide before you start taking carbamazepine tablets or chewable tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about carbamazepine tablets or chewable tablets?
Do not stop taking carbamazepine tablets or chewable tablets without first talking to your healthcare provider.
Stopping carbamazepine tablets or chewable tablets suddenly can cause serious problems.
Carbamazepine tablets or chewable tablets can cause serious side effects, including:
1.n- Carbamazepine tablets or chewable tablets may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine tablets or chewable tablets within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine tablets or chewable tablets to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:
2. Carbamazepine tablets or chewable tablets may cause rare but serious blood problems. Symptoms may include:
3. Like other antiepileptic drugs, carbamazepine tablets or chewable tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop carbamazepine tablets or chewable tablets without first talking to a healthcare provider.
Stopping carbamazepine tablets or chewable tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What are carbamazepine tablets or chewable tablets?
Carbamazepine tablets or chewable tablets are a prescription medicine used to treat:
Carbamazepine tablets or chewable tablets are not a regular pain medicine and should not be used for aches or pains.
Who should not take carbamazepine tablets or chewable tablets?
Do not take carbamazepine tablets or chewable tablets if you:
What should I tell my healthcare provider before taking carbamazepine tablets or chewable tablets?
Before you take carbamazepine tablets or chewable tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking carbamazepine tablets or chewable tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take carbamazepine tablets or chewable tablets?
What should I avoid while taking carbamazepine tablets or chewable tablets?
What are the possible side effects of carbamazepine tablets or chewable tablets?
See n n
Carbamazepine tablets or chewable tablets may cause other serious side effects. These include:
Get medical help right away if you have any of the symptoms listed above or listed in n n
The most common side effects of carbamazepine tablets or chewable tablets include:
These are not all the possible side effects of carbamazepine tablets or chewable tablets. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store carbamazepine tablets or chewable tablets?
Keep carbamazepine tablets or chewable tablets and all medicines out of the reach of children.
General Information about carbamazepine tablets or chewable tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use carbamazepine tablets or chewable tablets for a condition for which it was not prescribed. Do not give carbamazepine tablets or chewable tablets to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about carbamazepine tablets or chewable tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about carbamazepine tablets or chewable tablets that is written for health professionals.
For more information, call 1-269-544-2299.
What are the ingredients in carbamazepine tablets or chewable tablets?
Active ingredient: carbamazepine, USP
Inactive ingredients:
Carbamazepine tabletsn- :
Carbamazepine tablets (Chewable):
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Trademarks are the property of their respective owners.
Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.
8051524 Revised October 2014

No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of CARBAMAZEPINE (CARBAMAZEPINE) which is also known as CARBAMAZEPINE and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 200 mg/1.

CARBAMAZEPINE (CARBAMAZEPINE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.